Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Rhea-AI Summary

Mindset Pharma Inc. (CSE: MSET, OTCQB: MSSTF) announced on September 14, 2022, that it has received favorable Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its Phase 1 clinical trial of MSP-1014, its lead psychedelic drug candidate aimed at treating Major Depressive Disorders (MDD). The MHRA confirmed that no additional preclinical studies are required at this stage, and provided guidance on clinical trial design, dosing, and patient selection. MSP-1014 has shown improved efficacy and safety profiles in preclinical studies, prompting its advancement to human trials.

Positive

• Received favorable guidance from MHRA, confirming MSP-1014's readiness for Phase 1 clinical trials.
• No additional preclinical studies required, saving time and costs in development.
• MSP-1014 demonstrated improved efficacy and safety profiles in preclinical studies compared to psilocybin.

Negative

• None.

TORONTO, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that the Company has received Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) on a range of points to finalize its Phase 1 first-in-human clinical trial plan evaluating its lead psychedelic drug candidate MSP-1014 for the treatment of Major Depressive Disorders (MDD) .

In a meeting with the MHRA, Mindset discussed its plans for Phase 1 first-in-human clinical development of MSP-1014, a novel and patented, second-generation psilocybin-like drug candidate within Family 1, in collaboration with a specialized psychedelic UK-based Contract Research Organization (CRO), Clerkenwell Health. The MHRA has agreed with the Company’s position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time. The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.

In preclinical studies, MSP-1014, demonstrated an improved efficacy and safety profiles, with reduced potential side effects and faster onset of action, and similar duration of effect compared to the first-generation drug candidate psilocybin. Given its differentiation and improved pharmacological profile, Mindset prioritized moving MSP-1014 to first-in-human clinical studies.

“We are thrilled to have received this favorable written guidance from the MHRA, confirming the readiness of MSP-1014 for Phase 1 first-in-human clinical development. We have been working diligently to advance MSP-1014 through the regulatory process and with this guidance, we have taken yet another essential step toward clinical trials and will not be required to conduct additional preclinical safety studies at this time, which removes costly and time consuming steps,” said James Lanthier, CEO of Mindset Pharma. “Moving our lead drug candidate forward to human trials will contribute to Mindset’s goal of reaching patients suffering with mental health conditions who are waiting for new medicines with meaningful benefits.”

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Allison Soss
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267

Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 949-606-6585

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

Forward-Looking Information
This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

 

FAQ

What is MSP-1014 developed by Mindset Pharma?

MSP-1014 is a second-generation psychedelic drug candidate being developed to treat Major Depressive Disorders (MDD).

What did the MHRA confirm regarding MSP-1014?

The MHRA confirmed that MSP-1014 is ready for Phase 1 clinical trials and does not require additional preclinical studies.

What is the significance of the recent MHRA advice for Mindset Pharma?

The MHRA's favorable advice allows Mindset Pharma to proceed with clinical trials without the burden of extra preclinical studies, expediting the development process.

When will the Phase 1 trial for MSP-1014 begin?

The press release did not specify the exact start date for the Phase 1 trial, but indicated that progress is being made.

What are the expected benefits of MSP-1014 compared to earlier drugs?

MSP-1014 is expected to have a faster onset of action, reduced side effects, and similar duration of effect compared to the first-generation drug psilocybin.